FDA 510(k) Submission Timelines

[acro14]

Hi,

if your 510(k) submission is placed on hold and you want to submit a pre-submission for further clarification of outstanding issues does the pre-submission program prolong the timeline for the acceptance of a 510(k) or it remains the same resp. it is placed on hold during processing of the pre-submission?

 

[ascherp]

Hi,

No, they're independent from each other. The 180-day hold for your 510(k) submission of additional information remains and can't be extended.